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Other links at Articles > Business of Medicine |
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FDA Reprimands GlaxoSmithKline Over Missing Data on Rosiglitazone
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In a letter to GlaxoSmithKline, the FDA said that an inspection in late 2007 focusing on compliance with postmarketing adverse drug experience reporting requirements found that the company failed to report data from clinical usage and failed to disclose or submit data from clinical trials. Heartwire
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U.S. Democrats Object to Plan on Drug Label Changes
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Eight U.S. congressional Democrats urged the U.S. Food and Drug Administration on Wednesday to reconsider a plan that the lawmakers said would shield companies from liability rather than protect patients. Reuters Health Information
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Judge Denies Class in Fosamax Cases Against Merck
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A U.S. federal judge has denied motions to certify classes of users of osteoporosis drug Fosamax who wanted Merck & Co to set up a program to monitor them for an ailment involving jaw bone decay. Reuters Health Information
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